Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1

In brief

The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple 48 hours in an out-patient setting.

Key facts

Study ID

NCT02750267

Run by

University of Virginia

People needed

12

Starts

2016-05-01

Expected to finish

2016-05-01

Last updated by the study team

2017-07-24

Who can join

Age: 5 and older, up to 9. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of type 1 diabetes,
• The diagnosis of type 1 diabetes is based on the investigator's judgment
• C peptide levels and antibody determinations are not required
• Daily insulin therapy for ≥ 12 months
• Insulin pump therapy for ≥ 3 months
• Age ≥5 - ≤8 years old
• Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
• Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study

You may not qualify if…

• The presence of any of the following is an exclusion for the study:
• Diabetic ketoacidosis in the past month
• Hypoglycemic seizure or loss of consciousness in the past 3 months
• History of seizure disorder (except for hypoglycemic seizure)
• History of any heart disease including coronary artery disease, heart failure, or arrhythmias
• Cystic fibrosis
• Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
• History of ongoing renal disease (other than microalbuminuria).
• Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).
• Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
• Presence of a febrile illness within 24 hours of admission or acetaminophen use while wearing the CGM. The subject may be rescheduled for Research House/Hotel Admission if these criteria are not met. The study subject will not participate in the trial if these conditions are met.
• Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:
• Inpatient psychiatric treatment in the past 6 months
• Uncontrolled adrenal insufficiency

Where it is running

• University of Virginia Center for Diabetes Technology — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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